Rocket Pharma Says FDA Grants Fast Track And Orphan Drug Designations For RP-A601 Gene Therapy

RTTNews | Pred 710 dňami
Stocktwits
Rocket Pharma Says FDA Grants Fast Track And Orphan Drug Designations For RP-A601 Gene Therapy

(RTTNews) - Biotechnology company Rocket Pharmaceuticals, Inc. (RCKT) announced Thursday that the U.S. Food and Drug Administration (FDA) has granted Fast Track and Orphan Drug designations to RP-A601, the Company's gene therapy candidate for the treatment of plakophilin-2 related arrhythmogenic cardiomyopathy (PKP2-ACM).

RP-A601 is Rocket's adeno-associated virus (AAV.rh74)-based gene therapy for PKP2-ACM, a devastating, inherited heart disease associated with life-threatening arrhythmias, cardiac structural abnormalities, and sudden cardiac death.

Rocket recently announced FDA clearance of the Investigational New Drug (IND) application for RP-A601 based on robust preclinical proof of concept studies that demonstrated decreased arrhythmias and increased survival.

The Company is initiating a multi-center Phase 1, dose escalation trial that will evaluate the safety and preliminary efficacy of RP-A601 in at least six adult PKP2-ACM patients with ICDs and who have overall high risk for life-threatening arrhythmias.

For More Such Health News, visit rttnews.com

Značky: RCKT
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Taiwan Stock Market Tipped To Open In The Green

Taiwan Stock Market Tipped To Open In The Green

The Taiwan stock market bounced higher again on Friday, one day after snapping the four-day winning streak in which it had surged almost 1,250 points or 6.2 percent. The Taiwan Stock Exchange now sits just above the 21,840-point plateau although it's likely to tick higher again on Monday.
RTTNews | Pred 22 minútami
Higher Open Anticipated For Singapore Stock Market

Higher Open Anticipated For Singapore Stock Market

The Singapore stock market has moved higher in two straight sessions, collecting more than 25 points or 0.6 percent along the way. The Straits Times Index now sits just beneath the 3,900-point plateau and it may add to its winnings on Monday.
RTTNews | Pred 52 minútami
Malaysia Stock Market Tipped To Open To The Upside

Malaysia Stock Market Tipped To Open To The Upside

The Malaysia stock market has ticked lower in back-to-back sessions, shedding almost a dozen points or 0.8 percent along the way. The Kuala Lumpur Composite Index now sits just above the 1,570-point plateau although it may find support on Monday.
RTTNews | Pred 1 h 22 min
Japan Stock Market May Find Support On Monday

Japan Stock Market May Find Support On Monday

The Japanese stock market has moved lower in three straight sessions, dropping almost 450 points or 1.3 percent along the way. The Nikkei 225 now sits just above the 37,750-point plateau although it may find traction on Monday.
RTTNews | Pred 1 h 37 min
Additional Support Expected For South Korea Shares

Additional Support Expected For South Korea Shares

The South Korea stock market bounced higher again on Friday, one day after ending the three-day winning streak in which it had advanced more than 60 points or 2.4 percent. The KOSPI now sits just above the 2,625-point plateau and it may add to its winnings on Monday.
RTTNews | Pred 1 h 52 min
China Data On Tap For Monday

China Data On Tap For Monday

China is scheduled to release a batch of data on Monday, headlining a busy day for Asia-Pacific economic activity. On Tap are April figures for industrial production, retail sales, fixed asset investment, house prices and unemployment.
RTTNews | Pred 2 h 52 min
U.S. Dollar Higher On Trade Hopes

U.S. Dollar Higher On Trade Hopes

The U.S. dollar appreciated against its major counterparts in the New York session on Friday, as investors focused on developments on the trade front.
RTTNews | Pred 2 dňami
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